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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K011527
Device Name PRAXSYS RELIA TSH TEST
Applicant
Praxsys Biosystems, Inc.
12945 Alcosta Blvd.
San Ramon,  CA  94583
Applicant Contact RICHARD M THAYER
Correspondent
Praxsys Biosystems, Inc.
12945 Alcosta Blvd.
San Ramon,  CA  94583
Correspondent Contact RICHARD M THAYER
Regulation Number862.1690
Classification Product Code
JLW  
Date Received05/17/2001
Decision Date 08/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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